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Abstract Background Vulnerable children, including those with neuro-developmental delays and disabilities, often face barriers in accessing early primary education, thus hindering progress toward Sustainable Development Goal 4.2. Evidence-based interventions are essential to enhancing inclusivity and establishing sustainable implementation strategies to address this challenge. This study, Every Newborn—Reach up Early Education Intervention for All Children (EN-REACH), builds on the previous Every Newborn- Simplified Measurement Integrating Longitudinal Neurodevelopmental and Growth (EN-SMILING) observational cohort study. This paper provides the protocol for a cluster randomized controlled trial (cRCT) to evaluate the effectiveness of a parenting group intervention program for enhancing school readiness in Bangladesh, Nepal, and Tanzania, and an embedded process evaluation to inform scalability and feasibility. Methods EN-REACH is a cRCT with at least 150 clusters to evaluate the impact of a parent training program led by trained parent-teacher facilitator pairs, focusing on children aged 4 ~ 6 years preparing for preschool. Approximately 500 participants from the EN-SMILING cohort at each site have been identified. A geographic information system will define ~ 50 clusters in each of the three countries, each with approximately ten parent–child dyads. Half the clusters will be randomly assigned to intervention and control groups. The primary outcome is “school readiness”, assessed using the Measuring Early Learning Quality and Outcomes tool. Secondary outcomes include Intelligence Quotient, child functioning, growth, visual, and hearing assessments. Data will be collected at baseline, and post-intervention data following implementation of the parent group intervention sessions over approximately 5 months. Quantitative data on coverage and quality care, combined with qualitative insights from children, caregivers, facilitators, and stakeholders’ perspectives, will be used to conduct a process evaluation applying the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Discussion This protocol details a trial focused on enhancing school readiness and cognitive abilities in young children, inclusive of those with disabilities, aiming to bridge gap from home to early primary education. EN-REACH aims to provide insights into the effectiveness and acceptability of a co-designed disability-inclusive school readiness program in three countries, potentially impacting national and global policies for all children, including those with disabilities. Trial registration The trial was retrospectively registered on clinicaltrials.gov on 29 February 2024 (NCT06334627).

Background Globally, every year, approximately 1 million foetal deaths take place during the intrapartum period, fetal heart monitoring (FHRM) and timely intervention can reduce these deaths. Objective This study evaluates the implementation barriers and facilitators of a device, Moyo for FHRM. Methods The study adopted a qualitative study design in four hospitals in Nepal where Moyo was implemented for HRM. The study participants were labour room nurses and convenience sampling was used to select them. A total of 20 interviews were done to reach the data saturation. The interview transcripts were translated to English, and qualitative content analysis using deductive approach was applied. Results Using the deductive approach, the data were organised into three categories i) changes in practice of FHRM, ii) barriers to implementing Moyo and iii) facilitators of implementing Moyo. Moyo improved adherence to intermittent FHRM as the device could handle higher caseloads compared to the previous devices. The implementation of Moyo was hindered by difficulty to organise training ondevice during non-working hours, technical issue of the device, nurse mistrust towards the device and previous experience of poor implementation to similar innovations. Facilitators for implementation included effective training on how to use Moyo, improvement in intrapartum foetal monitoring and improvement in staff morale, ease of using the device, Plan Do Study Act (PDSA) meetings to improve use of Moyo and supportive leadership. Conclusion The change in FHRM practice suggests that the implementation of innovative solution such as Moyo was successful with adequate facilitation, supportive staff attitude and leadership.

Introduction The COVID-19 pandemic caused disruptions in global health and economic stability. In Nepal, before the pandemic, more than 50% of healthcare costs were out-of-pocket expenditure (OOPE). This study aimed to assess the OOPE for maternity care during before and during the COVID-19 pandemic in nine hospitals in Nepal.Method We conducted a before-and-after study between March 2019 and December 2020 with 13 months of prepandemic period and 9 months of pandemic period. OOPE was assessed using a semistructured interview with 53 864 women. Bivariate (unadjusted) and multivariate (adjusted) linear regression modelling was conducted to assess the change in OOPE in US dollar between the periods. Adjustment in linear regression model was done for population characteristics different between the periods.Result The OOPE for childbirth increased by 28.1% during pandemic, with an increase of OOPE from US$19.2 to S$23.9 (adjusted-β coefficient 5.4; 95% CI 4.5 to 5.7; p

Abstract Background Improving the healthcare providers (HCP) basic resuscitation skills can reduce intrapartum related mortality in low- and middle-income countries. However, the resuscitation intervention’s successful implementation is largely dependent on proper facilitation and context. This study aims to identify the facilitators and barriers for the implementation of a novel resuscitation package as part of the quality improvement project in Nepal. Methods The study used a qualitative descriptive design. The study sites included four purposively chosen public hospitals in Nepal, where the resuscitation package (Helping Babies Breathe [HBB] training, resuscitation equipment and NeoBeat) had been implemented as part of the quality improvement project. Twenty members of the HCP, who were trained and exposed to the package, were selected through convenience sampling to participate in the study interviews. Data were collected through semi-structured interviews conducted via telephone and video calls. Twenty interview data were analyzed with a deductive qualitative content analysis based on the core components of the i-PARiHS framework. Results The findings suggest that there was a move to more systematic resuscitation practices among the staff after the quality improvement project’s implementation. This positive change was supported by a neonatal heart rate monitor (NeoBeat), which guided resuscitation and made it easier. In addition, seeing the positive outcomes of successful resuscitation motivated the HCPs to keep practicing and developing their resuscitation skills. Facilitation by the project staff enabled the change. At the same time, facilitators provided extra support to maintain the equipment, which can be a challenge in terms of sustainability, after the project. Furthermore, a lack of additional resources, an unclear leadership role, and a lack of coordination between nurses and medical doctors were barriers to the implementation of the resuscitation package. Conclusion The introduction of the resuscitation package, as well as the continuous capacity building of local multidisciplinary healthcare staff, is important to continue the accelerated efforts of improving newborn care. To secure sustainable change, facilitation during implementation should focus on exploring local resources to implement the resuscitation package sustainably. Trial Registration Not applicable.

Abstract Background - An estimated 240,000 newborns die worldwide within 28 days of birth every year due to congenital birth defect. Exposure to poor indoor environment contributes to poor health outcomes. In this research, we aim to evaluate the association between the usage of different type household cooking fuel and congenital birth defects in Nepal, as well as investigate whether air ventilation usage had a modifying effect on the possible association. Methods - This is a secondary analysis of multi-centric prospective cohort study evaluating Quality Improvement Project in 12 public referral hospitals of Nepal from 2017 to 2018. The study sample was 66,713 women with a newborn, whose information was available in hospital records and exit interviews. The association between cooking fuel type usage and congenital birth defects was investigated with adjusted multivariable logistic regression. To investigate the air ventilation usage, a stratified multivariable logistic regression analysis was performed. Results -In the study population (N = 66,713), 60.0% used polluting fuels for cooking and 89.6% did not have proper air ventilation. The prevalence rate of congenital birth defect was higher among the families who used polluting fuels for cooking than those who used cleaner fuels (5.5/1000 vs. 3.5/1000, p

Objectives To evaluate the feasibility of using the NeuroMotion smartphone application for remote General Movements Assessment for screening infants for cerebral palsy in Kathmandu, Nepal.Method Thirty-one term-born infants at risk of cerebral palsy due to birth asphyxia or neonatal seizures were recruited for the follow-up at Paropakar Maternity and Women’s Hospital, 1 October 2021 to 7 January 2022. Parents filmed their children at home using the application at 3 months’ age and the videos were assessed for technical quality using a standardised form and for fidgety movements by Prechtl’s General Movements Assessment. The usability of the application was evaluated through a parental survey.Results Twenty families sent in altogether 46 videos out of which 35 had approved technical quality. Sixteen children had at least one video with approved technical quality. Three infants lacked fidgety movements. The level of agreement between assessors was acceptable (Krippendorf alpha 0.781). Parental answers to the usability survey were in general positive.Interpretation Engaging parents in screening of cerebral palsy with the help of a smartphone-aided remote General Movements Assessment is possible in the urban area of a South Asian lower middle-income country.

Abstract Background The COVID-19 pandemic has led to unprecedented mental stress to women after childbirth. In this study, we assessed the association of disrespectful care after childbirth and COVID-19 exposure before/during labour with postpartum depression symptoms assessed at 7 and 45 days in Nepal. Methods A longitudinal cohort study was conducted in 9 hospitals of Nepal among 898 women. The independent data collection system was established in each hospital to collection information on disrespectful care after birth via observation, exposure to COVID-19 infection before/during labour and other socio-demographic via interview. The information on depressive symptoms at 7 and 45 days was collected using the validated Edinburg Postnatal Depression Scale (EPDS) tool. Multi-level regression was performed to assess the association of disrespectful care after birth and COVID-19 exposure with postpartum depression. Result In the study, 16.5% were exposed to COVID-19 before/during labour and 41.8% of them received disrespectful care after childbirth. At 7 and 45 days postpartum, 21.3% and 22.4% of women reported depressive symptoms respectively. In the multi-level analysis, at the 7th postpartum day, women who had disrespectful care and no COVID-19 exposure still had 1.78 higher odds of having depressive symptom (aOR, 1.78; 95% CI; 1.16, 2.72). In the multi-level analysis, at 45th postpartum day, women who had disrespectful care and no COVID-19 exposure had 1.37 higher odds of having depressive symptoms (aOR, 1.37; 95% CI; 0.82, 2.30), but not statistically significant. Conclusion Disrespectful care after childbirth was strongly associated with postpartum depression symptoms irrespective of COVID-19 exposure during pregnancy. Caregivers, even during the global pandemic, should continue to focus their attention for immediate breast feeding and skin-to-skin contact, as this might reduce the risk for depressive symptoms postpartum.

Abstract Background Poor quality of maternal and newborn care contributes to nearly two million deaths of mothers and their newborns worldwide annually. Assessment of readiness and availability of perinatal care services in health facilities provides evidence to underlying bottlenecks for improving quality of care. This study aimed to evaluate the readiness and availability of perinatal care services in public hospitals of Nepal using WHO’s health system framework. Methods This was a mixed methods study conducted in 12 public hospitals in Nepal. A cross-sectional study design was used to assess the readiness and availability of perinatal care services. Three different data collection tools were developed. The tools were pretested in a tertiary maternity hospital and the discrepancies in the tools were corrected before administering in the study hospitals. The data were collected between July 2017 to July 2018. Results Only five out of 12 hospitals had the availability of all the basic newborn care services under assessment. Kangaroo mother care (KMC) service was lacking in most of the hospitals (7 out of 12). Only two hospitals had all health workers involved in perinatal care services trained in neonatal resuscitation. All of the hospitals were found not to have all the required equipment for newborn care services. Overall, only 60% of the health workers had received neonatal resuscitation training. A small proportion (3.2%) of the newborn infants with APGAR

Background Stimulating infants to elicit a cry at birth is common but could result in unnecessary handling. We evaluated heart rate in infants who were crying versus non-crying but breathing immediately after birth.Methods This was single-centre observational study of singleton, vaginally born infants at ≥33 weeks of gestation. Infants who were crying or non-crying but breathing within 30 s after birth were included. Background demographic data and delivery room events were recorded using tablet-based applications and synchronised with continuous heart rate data recorded by a dry-electrode electrocardiographic monitor. Heart rate centile curves for the first 3 min of life were generated with piecewise regression analysis. Odds of bradycardia and tachycardia were compared using multiple logistic regression.Results 1155 crying and 54 non-crying but breathing neonates were included in the final analyses. There were no significant differences in the demographic and obstetric factors between the cohorts. Non-crying but breathing infants had higher rates of early cord clamping

Abstract Background Timely initiation of breastfeeding can reduce neonatal morbidities and mortality. We aimed to study predictors for timely initiation of breastfeeding (within 1 h of birth) among neonates born in hospitals of Nepal. Method A prospective observational study was conducted in four public hospitals between July and October 2018. All women admitted in the hospital for childbirth and who consented were included in the study. An independent researchers observed whether the neonates were placed in skin-to-skin contact, delay cord clamping and timely initiation of breastfeeding. Sociodemographic variables, obstetric and neonate information were extracted from the maternity register. We analysed predictors for timely initiation of breastfeeding with Pearson chi-square test and multivariate logistic regression. Results Among the 6488 woman-infant pair observed, breastfeeding was timely initiated in 49.5% neonates. The timely initiation of breastfeeding was found to be higher among neonates who were placed skin-to-skin contact (34.9% vs 19.9%, p - value

Abstract Background Since the Millennium Development Goal era, there have been several efforts to increase institutional births using demand side financing. Since 2005, Government of Nepal has implemented Maternity Incentive Scheme (MIS) to reduce out of pocket expenditure (OOPE) for institutional birth. We aim to assess OOPE among women who had institutional births and coverage of MIS in Nepal. Method We conducted a prospective cohort study in 12 hospitals of Nepal for a period of 18 months. All women who were admitted in the hospital for delivery and consented were enrolled into the study. Research nurses conducted pre-discharge interviews with women on costs paid for medical services and non-medical services. We analysed the out of pocket expenditure by mode of delivery, duration of stay and hospitals. We also analysed the coverage of maternal incentive scheme in these hospitals. Results Among the women (n-21,697) reporting OOPE, the average expenditure per birth was 41.5 USD with 36 % attributing to transportation cost. The median OOPE was highest in Bheri hospital (60.3 USD) in comparison with other hospitals. The OOPE increased by 1.5 USD (1.2, 1.8) with each additional day stay in the hospital. There was a difference in the OOPE by mode of delivery, duration of hospital-stay and hospital of birth. The median OOPE was high among the caesarean birth with 43.3 USD in comparison with vaginal birth, 32.6 USD. The median OOPE was 44.7 USD, if the women stayed for 7 days and 33.5 USD if the women stayed for 24 h. The OOPE increased by 1.5 USD with each additional day of hospital stay after 24 h. The coverage of maternal incentive was 96.5 % among the women enrolled in the study. Conclusions Families still make out of pocket expenditure for institutional birth with a large proportion attributed to hospital care. OOPE for institutional births varied by duration of stay and mode of birth. Given the near universal coverage of incentive scheme, there is a need to review the amount of re-imbursement done to women based on duration of stay and mode of birth.

Abstract Background High-quality resuscitation among non-crying babies immediately after birth can reduce intrapartum-related deaths and morbidity. Helping Babies Breathe program aims to improve performance on neonatal resuscitation care in resource-limited settings. Quality improvement (QI) interventions can sustain simulated neonatal resuscitation knowledge and skills and clinical performance. This study aimed to evaluate the effect of a scaled-up QI intervention package on the performance of health workers on basic neonatal resuscitation care among non-crying infants in public hospitals in Nepal. Methods A prospective observational cohort design was applied in four public hospitals of Nepal. Performances of health workers on basic neonatal care were analysed before and after the introduction of the QI interventions. Results Out of the total 32,524 births observed during the study period, 3031 newborn infants were not crying at birth. A lower proportion of non-crying infants were given additional stimulation during the intervention compared to control (aOR 0.18; 95% CI 0.13–0.26). The proportion of clearing the airway increased among non-crying infants after the introduction of QI interventions (aOR 1.23; 95% CI 1.03–1.46). The proportion of non-crying infants who were initiated on BMV was higher during the intervention period (aOR 1.28, 95% CI 1.04–1.57) compared to control. The cumulative median time to initiate ventilation during the intervention was 39.46 s less compared to the baseline. Conclusion QI intervention package improved health workers’ performance on the initiation of BMV, and clearing the airway. The average time to first ventilation decreased after the implementation of the package. The QI package can be scaled-up in other public hospitals in Nepal and other similar settings.

Abstract Background Annually, 14 million newborns require stimulation to initiate breathing at birth and 6 million require bag-mask-ventilation (BMV). Many countries have invested in facility-based neonatal resuscitation equipment and training. However, there is no consistent tracking for neonatal resuscitation coverage. Methods The EN-BIRTH study, in five hospitals in Bangladesh, Nepal, and Tanzania (2017–2018), collected time-stamped data for care around birth, including neonatal resuscitation. Researchers surveyed women and extracted data from routine labour ward registers. To assess accuracy, we compared gold standard observed coverage to survey-reported and register-recorded coverage, using absolute difference, validity ratios, and individual-level validation metrics (sensitivity, specificity, percent agreement). We analysed two resuscitation numerators (stimulation, BMV) and three denominators (live births and fresh stillbirths, non-crying, non-breathing). We also examined timeliness of BMV. Qualitative data were collected from health workers and data collectors regarding barriers and enablers to routine recording of resuscitation. Results Among 22,752 observed births, 5330 (23.4%) babies did not cry and 3860 (17.0%) did not breathe in the first minute after birth. 16.2% (n = 3688) of babies were stimulated and 4.4% (n = 998) received BMV. Survey-report underestimated coverage of stimulation and BMV. Four of five labour ward registers captured resuscitation numerators. Stimulation had variable accuracy (sensitivity 7.5–40.8%, specificity 66.8–99.5%), BMV accuracy was higher (sensitivity 12.4–48.4%, specificity > 93%), with small absolute differences between observed and recorded BMV. Accuracy did not vary by denominator option.

Abstract Background Kangaroo mother care (KMC) reduces mortality among stable neonates ≤2000 g. Lack of data tracking coverage and quality of KMC in both surveys and routine information systems impedes scale-up. This paper evaluates KMC measurement as part of the Every Newborn Birth Indicators Research Tracking in Hospitals (EN-BIRTH) study. Methods The EN-BIRTH observational mixed-methods study was conducted in five hospitals in Bangladesh, Nepal and Tanzania from 2017 to 2018. Clinical observers collected time-stamped data as gold standard for mother-baby pairs in KMC wards/corners. To assess accuracy, we compared routine register-recorded and women’s exit survey-reported coverage to observed data, using different recommended denominator options (≤2000 g and ≤ 2499 g). We analysed gaps in quality of provision and experience of KMC. In the Tanzanian hospitals, we assessed daily skin-to-skin duration/dose and feeding frequency. Qualitative data were collected from health workers and data collectors regarding barriers and enablers to routine register design, filling and use. Results Among 840 mother-baby pairs, compared to observed 100% coverage, both exit-survey reported (99.9%) and register-recorded coverage (92.9%) were highly valid measures with high sensitivity. KMC specific registers outperformed general registers. Enablers to register recording included perceptions of data usefulness, while barriers included duplication of data elements and overburdened health workers. Gaps in KMC quality were identified for position components including wearing a hat. In Temeke Tanzania, 10.6% of babies received daily KMC skin-to-skin duration/dose of ≥20 h and a further 75.3% received 12–19 h. Regular feeding ≥8 times/day was observed for 36.5% babies in Temeke Tanzania and 14.6% in Muhimbili Tanzania. Cup-feeding was the predominant assisted feeding method. Family support during admission was variable, grandmothers co-provided KMC more often in Bangladesh. No facility arrangements for other family members were reported by 45% of women at exit survey. Conclusions Routine hospital KMC register data have potential to track coverage from hospital KMC wards/corners. Women accurately reported KMC at exit survey and evaluation for population-based surveys could be considered. Measurement of content, quality and experience of KMC need consensus on definitions. Prioritising further KMC measurement research is important so that high quality data can be used to accelerate scale-up of high impact care for the most vulnerable.

Abstract Background Observation of care at birth is challenging with multiple, rapid and potentially concurrent events occurring for mother, newborn and placenta. Design of electronic data (E-data) collection needs to account for these challenges. The Every Newborn Birth Indicators Research Tracking in Hospitals (EN-BIRTH) was an observational study to assess measurement of indicators for priority maternal and newborn interventions and took place in five hospitals in Bangladesh, Nepal and Tanzania (July 2017–July 2018). E-data tools were required to capture individually-linked, timed observation of care, data extraction from hospital register-records or case-notes, and exit-survey data from women. Methods To evaluate this process for EN-BIRTH, we employed a framework organised around five steps for E-data design, data collection and implementation. Using this framework, a mixed methods evaluation synthesised evidence from study documentation, standard operating procedures, stakeholder meetings and design workshops. We undertook focus group discussions with EN-BIRTH researchers to explore experiences from the three different country teams (November–December 2019). Results were organised according to the five a priori steps. Results In accordance with the five-step framework, we found: 1) Selection of data collection approach and software: user-centred design principles were applied to meet the challenges for observation of rapid, concurrent events around the time of birth with time-stamping. 2) Design of data collection tools and programming: required extensive pilot testing of tools to be user-focused and to include in-built error messages and data quality alerts. 3) Recruitment and training of data collectors: standardised with an interactive training package including pre/post-course assessment. 4) Data collection, quality assurance, and management: real-time quality assessments with a tracking dashboard and double observation/data extraction for a 5% case subset, were incorporated as part of quality assurance. Internet-based synchronisation during data collection posed intermittent challenges. 5) Data management, cleaning and analysis: E-data collection was perceived to improve data quality and reduce time cleaning. Conclusions The E-Data system, custom-built for EN-BIRTH, was valued by the site teams, particularly for time-stamped clinical observation of complex multiple simultaneous events at birth, without which the study objectives could not have been met. However before selection of a custom-built E-data tool, the development time, higher training and IT support needs, and connectivity challenges need to be considered against the proposed study or programme’s purpose, and currently available E-data tool options.

Abstract Background An estimated >2 million babies stillborn around the world each year lack visibility. Low- and middle-income countries carry 84% of the burden yet have the least data. Most births are now in facilities, hence routine register-recording presents an opportunity to improve counting of stillbirths, but research is limited, particularly regarding accuracy. This paper evaluates register-recorded measurement of hospital stillbirths, classification accuracy, and barriers and enablers to routine recording. Methods The EN-BIRTH mixed-methods, observational study took place in five hospitals in Bangladesh, Nepal and Tanzania (2017–2018). Clinical observers collected time-stamped data on perinatal care and birth outcomes as gold standard. To assess accuracy of routine register-recorded stillbirth rates, we compared birth outcomes recorded in labour ward registers to observation data. We calculated absolute rate differences and individual-level validation metrics (sensitivity, specificity, percent agreement). We assessed misclassification of stillbirths with neonatal deaths. To examine stillbirth appearance (fresh/macerated) as a proxy for timing of death, we compared appearance to observed timing of intrauterine death based on heart rate at admission. Results 23,072 births were observed including 550 stillbirths. Register-recorded completeness of birth outcomes was > 90%. The observed study stillbirth rate ranged from 3.8 (95%CI = 2.0,7.0) to 50.3 (95%CI = 43.6,58.0)/1000 total births and was under-estimated in routine registers by 1.1 to 7.3 /1000 total births (register: observed ratio 0.9–0.7). Specificity of register-recorded birth outcomes was > 99% and sensitivity varied between hospitals, ranging from 77.7–86.1%. Percent agreement between observer-assessed birth outcome and register-recorded birth outcome was very high across all hospitals and all modes of birth (> 98%). Fresh or macerated stillbirth appearance was a poor proxy for timing of stillbirth. While there were similar numbers of stillbirths misclassified as neonatal deaths (17/430) and neonatal deaths misclassified as stillbirths (21/36), neonatal deaths were proportionately more likely to be misclassified as stillbirths (58.3% vs 4.0%). Enablers to more accurate register-recording of birth outcome included supervision and data use. Conclusions Our results show these routine registers accurately recorded stillbirths. Fresh/macerated appearance was a poor proxy for intrapartum stillbirths, hence more focus on measuring fetal heart rate is crucial to classification and importantly reduction in these preventable deaths.

Abstract Background Respectful maternal and newborn care (RMNC) is an important component of high-quality care but progress is impeded by critical measurement gaps for women and newborns. The Every Newborn Birth Indicators Research Tracking in Hospitals (EN-BIRTH) study was an observational study with mixed methods assessing measurement validity for coverage and quality of maternal and newborn indicators. This paper reports results regarding the measurement of respectful care for women and newborns. Methods At one EN-BIRTH study site in Pokhara, Nepal, we included additional questions during exit-survey interviews with women about their experiences (July 2017–July 2018). The questionnaire was based on seven mistreatment typologies: Physical; Sexual; or Verbal abuse; Stigma/discrimination; Failure to meet professional standards of care; Poor rapport between women and providers; and Health care denied due to inability to pay. We calculated associations between these typologies and potential determinants of health – ethnicity, age, sex, mode of birth – as possible predictors for reporting poor care. Results Among 4296 women interviewed, none reported physical, sexual, or verbal abuse. 15.7% of women were dissatisfied with privacy, and 13.0% of women reported their birth experience did not meet their religious and cultural needs. In descriptive analysis, adjusted odds ratios and multivariate analysis showed primiparous women were less likely to report respectful care (β = 0.23, p-value

Abstract Background Population-based household surveys, notably the Demographic and Health Surveys (DHS) and Multiple Indicator Cluster Surveys (MICS), remain the main source of maternal and newborn health data for many low- and middle-income countries. As part of the Every Newborn Birth Indicators Research Tracking in Hospitals (EN-BIRTH) study, this paper focuses on testing validity of measurement of maternal and newborn indicators around the time of birth (intrapartum and postnatal) in survey-report. Methods EN-BIRTH was an observational study testing the validity of measurement for selected maternal and newborn indicators in five secondary/tertiary hospitals in Bangladesh, Nepal and Tanzania, conducted from July 2017 to July 2018. We compared women’s report at exit survey with the gold standard of direct observation or verification from clinical records for women with vaginal births. Population-level validity was assessed by validity ratios (survey-reported coverage: observer-assessed coverage). Individual-level accuracy was assessed by sensitivity, specificity and percent agreement. We tested indicators already in DHS/MICS as well as indicators with potential to be included in population-based surveys, notably the first validation for small and sick newborn care indicators. Results 33 maternal and newborn indicators were evaluated. Amongst nine indicators already present in DHS/MICS, validity ratios for baby dried or wiped, birthweight measured, low birthweight, and sex of baby (female) were between 0.90–1.10. Instrumental birth, skin-to-skin contact, and early initiation of breastfeeding were highly overestimated by survey-report (2.04–4.83) while umbilical cord care indicators were massively underestimated (0.14–0.22). Amongst 24 indicators not currently in DHS/MICS, two newborn contact indicators (kangaroo mother care 1.00, admission to neonatal unit 1.01) had high survey-reported coverage amongst admitted newborns and high sensitivity. The remaining indicators did not perform well and some had very high “don’t know” responses. Conclusions Our study revealed low validity for collecting many maternal and newborn indicators through an exit survey instrument, even with short recall periods among women with vaginal births. Household surveys are already at risk of overload, and some specific clinical care indicators do not perform well and may be under-powered. Given that approximately 80% of births worldwide occur in facilities, routine registers should also be explored to track coverage of key maternal and newborn health interventions, particularly for clinical care.

Abstract Background Sustainable Development Goal (SDG) aspires to improve universal health coverage through reduction of Out of Pocket Expenditure (OOPE) and improving the quality of care. In the last two decades, there have been several efforts to reduce the OOPE for maternal and newborn care. In this paper, we evaluate the change in the OOPE for treatment of sick newborn at hospital before and after implementation of a free newborn care (FNC) program in hospitals of Nepal. Methods Ministry of Health and Population implemented a free newborn care program which reimbursed the cost of treatment for all sick newborns admitted in public hospitals in Nepal from November 2017. We conducted this pre-post quasi-experimental study with four months of pre-implementation and 12 months of post-implementation of the program in 12 hospitals of Nepal. Logistic regression analysis was conducted for categorical variables and Mann-Whitney test was applied for continuous variables to determine statistically significant differences between pre- and post- intervention period. Results A total of 353 sick newborns were admitted into these hospitals before implementation of the FNC program while 1122 sick newborns were admitted after the implementation. Before implementation, 17 % of mothers paid for sick newborn care while after implementation 15.3 % mothers (p-value = 0.59) paid for care. The OOPE for treatment of sick newborn at hospital before implementation was Mean ± SD: US dollar 14.3 + 12.1 and after implementation was Mean ± SD: USD 13.0 ± 9.6 (p-value = 0.71). There were no significant differences in neonatal morbidity after the implementation of the FNC program. The stay in a hospital bed (in days) decreased after the implementation of FNC program (p-value

Abstract Background Simulation-based training in neonatal resuscitation is more effective when reinforced by both practice and continuous improvement processes. We aim to evaluate the effectiveness of a quality improvement program combined with an innovative provider feedback device on neonatal resuscitation practice and outcomes in a public referral hospital of Nepal. Methods A pre- and post-intervention study will be implemented in Pokhara Academy of Health Sciences, a hospital with 8610 deliveries per year. The intervention package will include simulation-based training (Helping Babies Breathe) enhanced with a real-time feedback system (the NeoBeat newborn heart rate meter with the NeoNatalie Live manikin and upright newborn bag-mask with PEEP) accompanied by a quality improvement process. An independent research team will collect perinatal data and conduct stakeholder interviews. Discussion This study will provide further information on the efficiency of neonatal resuscitation training and implementation in the context of new technologies and quality improvement processes. Trial registration https://doi.org/10.1186/ISRCTN18148368 , date of registration-31 July 2018

Abstract Background Neonatal sepsis is one of the major causes of death during the first month of life and early empirical treatment with injectable antibiotics is a life-saving intervention. Adherence to World Health Organisation guidelines on first line antibiotics is crucial to mitigate the risks of increased antimicrobial resistance. The aim of this paper was to evaluate if treatment of early onset neonatal sepsis in a low-income facility setting observe current guidelines and if compliance is influenced by contextual factors. Methods This cohort study used data on antimicrobial treatment of neonatal sepsis onset within 72 h of life from 12 regional hospitals participating in a scale-up trial of a neonatal resuscitation quality improvement package intervention in Nepal. Infants treated according to guidelines were compared with those receiving other antimicrobials. A multiple logistic regression analysis adjusted for the intervention and time trend was applied. Results 1564 infants with a preliminary diagnosis of early onset sepsis were included. A majority (74.9%) were treated according to guidelines and adherence was increasing over time. Infants born at larger facilities (adjusted Odds Ratio 5.6), those that were inborn (adjusted Odds Ratio 1.97) or belonging to a family of dis-advantaged caste (adjusted Odds Ratio 2.15) had higher odds for treatment according to guidelines. A clinical presentation of lethargy or tachypnoea was associated with adherence to guidelines. Conclusion Adherence to guidelines for antibiotic treatment of early neonatal sepsis was moderately high in this low-income setting. Odds for observing guidelines increased with facility size, for inborn infants and if the family belonged to a dis-advantaged caste. Cefotaxime was a common alternative choice when guidelines were not followed, highly relevant for the risk of increased antimicrobial resistance. Trial registration ISRCTN, ISRCTN30829654 , registered 17th of May, 2017.

Abstract Background Countries with the highest burden of maternal and newborn deaths and stillbirths often have little information on these deaths. Since over 81% of births worldwide now occur in facilities, using routine facility data could reduce this data gap. We assessed the availability, quality, and utility of routine labour and delivery ward register data in five hospitals in Bangladesh, Nepal, and Tanzania. This paper forms the baseline register assessment for the Every Newborn-Birth Indicators Research Tracking in Hospitals (EN-BIRTH) study. Methods We extracted 21 data elements from routine hospital labour ward registers, useful to calculate selected maternal and newborn health (MNH) indicators. The study sites were five public hospitals during a one-year period (2016–17). We measured 1) availability: completeness of data elements by register design, 2) data quality: implausibility, internal consistency, and heaping of birthweight and explored 3) utility by calculating selected MNH indicators using the available data. Results Data were extracted for 20,075 births. Register design was different between the five hospitals with 10–17 of the 21 selected MNH data elements available. More data were available for health outcomes than interventions. Nearly all available data elements were > 95% complete in four of the five hospitals and implausible values were rare. Data elements captured in specific columns were 85.2% highly complete compared to 25.0% captured in non-specific columns. Birthweight data were less complete for stillbirths than live births at two hospitals, and significant heaping was found in all sites, especially at 2500g and 3000g. All five hospitals recorded count data required to calculate impact indicators including; stillbirth rate, low birthweight rate, Caesarean section rate, and mortality rates. Conclusions Data needed to calculate MNH indicators are mostly available and highly complete in EN-BIRTH study hospital routine labour ward registers in Bangladesh, Nepal and Tanzania. Register designs need to include interventions for coverage measurement. There is potential to improve data quality if Health Management Information Systems utilization with feedback loops can be strengthened. Routine health facility data could contribute to reduce the coverage and impact data gap around the time of birth.

Objective Inadequate adherence to resuscitation for non-crying infants will have poor outcome and thus rationalise a need for real-time guidance and quality improvement technology. This study assessed the usability, feasibility and acceptability of a novel technology of real-time visual guidance, with sound and video recording during resuscitation.Setting A public hospital in Nepal.Design A cross-sectional design.Intervention The technology has an infant warmer with light, equipped with a tablet monitor, NeoBeat and upright bag and mask. The tablet records resuscitation activities, ventilation sound, heart rate and display time since birth. Healthcare providers (HCPs) were trained on the technology before piloting.Data collection and analysis HCPs who had at least 8 weeks of experience using the technology completed a questionnaire on usability, feasibility and acceptability (ranged 1–5 scale). Overall usability score was calculated (ranged 1–100 scale).Results Among the 30 HCPs, 25 consented to the study. The usability score was good with the mean score (SD) of 68.4% (10.4). In terms of feasibility, the participants perceived that they did not receive adequate support from the hospital administration for use of the technology, mean score (SD) of 2.44 (1.56). In terms of acceptability, the information provided in the monitor, that is, time elapsed from birth was easy to understand with mean score (SD) of 4.60 (0.76).Conclusion The study demonstrates reasonable usability, feasibility and acceptability of a technological solution that records audio visual events during resuscitation and provides visual guidance to improve care.

BackgroundPoor quality of intrapartum care remains a global health challenge for reducing stillbirth and early neonatal mortality. Despite fetal heart rate monitoring (FHRM) being key to identify fetus at risk during labor, sub-optimal care prevails in low-income settings. The study aims to assess the predictors of suboptimal fetal heart rate monitoring and assess the association of sub-optimal FHRM and intrapartum related deaths.MethodA prospective cohort study was conducted in 12 hospitals between April 2017 to October 2018. Pregnant women with fetal heart sound present during admission were included. Inferential statistics were used to assess proportion of sub-optimal FHRM. Multi-level logistic regression was used to detect association between sub-optimal FHRM and intrapartum related death.ResultThe study cohort included 83,709 deliveries, in which in more than half of women received suboptimal FHRM (56%). The sub-optimal FHRM was higher among women with obstetric complication than those with no complication (68.8% vs 55.5%, p-valueConclusionAdherence to FHRM as per clinical standards was inadequate in these hospitals of Nepal. Furthermore, there was an increased odds of intra-partum death if FHRM had not been carried out as per clinical standards. FHRM provided as per protocol is key to identify fetuses at risk, and efforts are needed to improve the adherence of quality of care to prevent death.

Introduction Adherence to intrapartum fetal heart rate monitoring (FHRM) for early decision making in high-risk pregnancies remains a global health challenge. COVID-19 has led to disruption of routine intrapartum care in all income settings. This study aims to evaluate the implementation of quality improvement (QI) intervention to improve intrapartum FHRM and birth outcome before and during pandemic. Method and materials We conducted an observational study among 10,715 pregnant women in a hospital of Nepal, over 25 months. The hospital implemented QI intervention i.e facilitated plan-do-study-act (PDSA) meetings before and during pandemic. We assessed the change in intrapartum FHRM, timely action in high-risk deliveries and fetal outcomes before and during pandemic. Results The number of facilitated PDSA meetings increased from an average of one PDSA meeting every 2 months before pandemic to an average of one PDSA meeting per month during the pandemic. Monitoring and documentation of intrapartum FHRM at an interval of less than 30 minutes increased from 47% during pre-pandemic to 73.3% during the pandemic (pConclusion Despite implementation of QI intervention during the pandemic, the constrains in human resource to manage high risk women has led to poorer neonatal outcome. Increasing human resources to manage high risk women will be key to timely action among high-risk women and prevent stillbirth.

Background Stimulation of non-crying neonates after birth can help transition to spontaneous breathing. In this study, we aim to assess the impact of intact versus clamped umbilical cord on spontaneous breathing after stimulation of non-crying neonates.Methods This is an observational study among non-crying neonates (n=3073) born in hospitals of Nepal. Non-crying neonates born vaginally at gestational age ≥34 weeks were observed for their response to stimulation with the cord intact or clamped. Obstetric characteristics of the neonates were analysed. Association of spontaneous breathing with cord management was assessed using logistic regression.Results Among non-crying neonates, 2563 received stimulation. Of these, a higher proportion of the neonates were breathing in the group with cord intact as compared with the group cord clamped (81.1% vs 68.9%, p

Abstract Aim Maintaining neonatal resuscitation skills among health workers in low resource settings will require continuous quality improvement efforts. We aimed to evaluate the effect of skill drills and feedback on neonatal resuscitation and the optimal number of skill drills required to maintain the ventilation skill in a simulated setting. Methods An observational study was conducted for a period of 3 months in a referral hospital of Nepal. Sixty nursing staffs were trained on Helping Babies Breathe (HBB) 2.0 and daily skill drills using a high-fidelity manikin. The high-fidelity manikin had different clinical case scenarios and provided feedback as “well done” or “improvement required” based on the ventilation performance. Adequate ventilation was defined as bag-and-mask ventilation at the rate of 40–60 breaths per minute. The effective ventilation was defined as adequate ventilation with a “well done” feedback. We assessed the correlation of number skill drills and clinical case scenario with adequate ventilation rate using pearson’s correlation. We assessed the correlation of number of skill dills performed by each participant with effective ventilation using Mann Whitney test. Results Among the total of 60 nursing staffs, all of them were competent with an average score of 12.73 ± 1.09 out of 14 (p

Abstract Background Experiments have shown improved cardiovascular stability in lambs if umbilical cord clamping is postponed until positive pressure ventilation is started. Studies on intact cord resuscitation on human term infants are sparse. The purpose of this study was to evaluate differences in clinical outcomes in non-breathing infants between groups, one where resuscitation is initiated with an intact umbilical cord (intervention group) and one group where cord clamping occurred prior to resuscitation (control group). Methods Randomized controlled trial, inclusion period April to August 2016 performed at a tertiary hospital in Kathmandu, Nepal. Late preterm and term infants born vaginally, non-breathing and in need of resuscitation according to the ‘Helping Babies Breathe’ algorithm were randomized to intact cord resuscitation or early cord clamping before resuscitation. Main outcome measures were saturation by pulse oximetry (SpO2), heart rate and Apgar at 1, 5 and 10 minutes after birth. Results At 10 minutes after birth, SpO2 (SD) was significantly higher in the intact cord group compared to the early cord clamping group, 90.4 (8.1) vs 85.4 (2.7) %, P

BackgroundHelping Babies Breathe (HBB) training improves bag and mask ventilation and reduces neonatal mortality and fresh stillbirths. Quality improvement (QI) interventions can improve retention of neonatal resuscitation knowledge and skills. This study aimed to evaluate the effect of a scaled-up QI intervention package on uptake and retention of neonatal resuscitation knowledge and skills in simulated settings.MethodsThis was a pre-post study in 12 public hospitals of Nepal. Knowledge and skills of trainees on neonatal resuscitation were evaluated against the set standard before and after the introduction of QI interventions.ResultsAltogether 380 participants were included for knowledge evaluation and 286 for skill evaluation. The overall knowledge test score increased from 14.12 (pre-basic) to 15.91 (post-basic) during basic training (p < 0.001). The knowledge score decreased over time; 15.91 (post-basic) vs. 15.33 (pre-refresher) (p < 0.001). Overall skill score during basic training (16.98 ± 1.79) deteriorated over time to 16.44 ± 1.99 during refresher training (p < 0.001). The proportion of trainees passing the knowledge test increased to 91.1% (post-basic) from 67.9% (pre-basic) which decreased to 86.6% during refresher training after six months. The knowledge and skill scores were maintained above the set standard (>14.0) over time at all hospitals during refresher training.ConclusionHBB training together with QI tools improves health workers' knowledge and skills on neonatal resuscitation, irrespective of size and type of hospitals. The knowledge and skills deteriorate over time but do not fall below the standard. The HBB training together with QI interventions can be scaled up in other public hospitals.Trial registrationThis study was part of the larger Nepal Perinatal Quality Improvement Project (NePeriQIP) with International Standard Randomised Controlled Trial Number, ISRCTN30829654, registered 17th of May, 2017.

BACKGROUND:Improving quality of intrapartum care will reduce intrapartum stillbirth and neonatal mortality, especially in resource-poor settings. Basic neonatal resuscitation can reduce intrapartum stillbirth and early neonatal mortality, if delivered in a high-quality health system, but there is a dearth of evidence on how to scale up such evidence-based interventions. We evaluated the scaling up of a quality improvement (QI) package for neonatal resuscitation on intrapartum-related mortality (intrapartum stillbirth and first day mortality) at hospitals in Nepal. METHODS AND FINDINGS:We conducted a stepped-wedge cluster randomized controlled trial in 12 hospitals over a period of 18 months from April 14, 2017, to October 17, 2018. The hospitals were assigned to one of four wedges through random allocation. The QI package was implemented in a stepped-wedge manner with a delay of three months for each step. The QI package included improving hospital leadership on intrapartum care, building health workers' competency on neonatal resuscitation, and continuous facilitated QI processes in clinical units. An independent data collection system was set up at each hospital to gather data on mortality through patient case note review and demographic characteristics of women using semi-structured exit interviews. The generalized linear mixed model (GLMM) and multivariate logistic regression were used for analyses. During this study period, a total of 89,014 women-infant pairs were enrolled. The mean age of the mother in the study period was 24.0 ± 4.3 years, with 54.9% from disadvantaged ethnic groups and 4.0% of them illiterate. Of the total birth cohort, 54.4% were boys, 16.7% had gestational age less than 37 weeks, and 17.1% had birth weight less than 2,500 grams. The incidence of intrapartum-related mortality was 11.0 per 1,000 births during the control period and 8.0 per 1,000 births during the intervention period (adjusted odds ratio [aOR], 0.79; 95% CI, 0.69-0.92; p = 0.002; intra-cluster correlation coefficient [ICC], 0.0286). The incidence of early neonatal mortality was 12.7 per 1,000 live births during the control period and 10.1 per 1,000 live births during the intervention period (aOR, 0.89; 95% CI, 0.78-1.02; p = 0.09; ICC, 0.1538). The use of bag-and-mask ventilation for babies with low Apgar score (